Week In Review: Yantai's MabPlex Raises $59 Million To Expand CDMO Services

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Includes: AZN, BGNE, CBMG, IRWD
by: ChinaBio Today
Summary

Luye Pharma out-licensed mainland China marketing rights for its anti-cholesterol Xuezhikang capsules to AstraZeneca China.

Ironwood Pharma reported that China approved its treatment for irritable bowel syndrome with constipation (IBS-C).

Cellular Biomedicine, a Shanghai immunotherapy/stem cell company, reported that its off-the-shelf therapy for Knee Osteoarthritis (KOA) was approved to start a China Phase II trial.

Deals and Financings

MabPlex, a biologics CDMO located in Yantai, raised $59 million in a Series A round from SDIC Venture Fund and Shenzhen Venture Capital, two state-owned investors. Founded in 2013, MabPlex offers biologics development and manufacturing services, including mAbs, recombinant proteins, ADCs and bispecifics. Its offerings range from gene sequencing to cell line development and commercial production. MabPlex's CHO cell line platform is designed to move candidates in the shortest possible time from DNA to finished product. In 2018, MabPlex opened a US site in San Diego.

Tyto Care, an Israeli telehealth company, raised $9 million from strategic investors Sanford Health, Itochu and Shenzhen Capital Group in a continuation of its Series C funding. One year ago, Tyto Care announced the initial closing of the Series C round with $25 million led by China's Ping An Voyager Fund. Tyto makes a device that, in combination with a home computer, allows a doctor to conduct an online home examination of the patient. The $299 Tyto device (plus monthly fee) is sold by healthcare organizations to their patients.

Ascletis Pharma (HK:1672) of Hangzhou acquired China rights to a Suzhou Alphamab anti-PD-L1 candidate for hepatitis B and other viral disease indications. Ascletis will make an upfront payment, and Alphamab will be eligible to receive payments for development and commercial milestones plus royalties ranging from the mid-teens to around twenty percent. Alphamab will manufacture the candidate. Ascletis will be eligible to share in future upfront, milestone and royalty if ASC22 (KN035) is approved to treat viral diseases outside of Greater China.

Bio-Thera Solutions, a Guangzhou biopharma, out-licensed marketing rights for its Avastin biosimilar to India's Cipla (BSE:500087) in certain emerging markets. The agreement is a rare China-Indian biopharma agreement. Cipla was chosen because it has a strong presence in emerging markets. Bio-Thera's BAT-1706 is currently being tested in a global Phase III study as a first-line therapy for advanced non-squamous non-small cell lung cancer. The company expects to file for approval of the biosimilar in China, the US and Europe in 2020.

Luye Pharma (HK:8126) out-licensed mainland China marketing rights for its anti-cholesterol Xuezhikang capsules to AstraZeneca China (NYSE:AZN) (see story). Xuezhikang is a fermented form of red yeast rice that is similar to a statin. It has successfully completed US Phase II trials, and the two companies are considering expanding distribution to the US, Europe and emerging markets. They expect Xuezhikang revenues will continue growing at a double-digit rate. The partnership is the first time a China biopharma has partnered China product rights with a multinational company for a product it developed.

Nanning Xinzizhu Trading acquired China distribution rights to a medical device aimed at treating chronic wounds made by AOTI of Oceanside, CA. AOTI developed the Topical Wound Oxygen (TWO2) device that delivers oxygen to chronic wounds, especially diabetic ulcers. Initially, both AOTI and Xinzizhu will work together to obtain NMPA registration of the TWO2 product line, while they increase awareness of the new device. The two companies signed a multi-year agreement that includes minimum sales totaling close to $18 million.

Company News

Boehringer Ingelheim has begun an expansion of Oasis, its Shanghai biologic contract manufacturing facility, including an additional bioreactor and sufficient infrastructure to support the GMP operations of 2x2000L single use bioreactor manufacturing lines. BI explained that one of its contracted mAbs is close to commercial production, with several additional candidates in its pipeline expected to follow soon. It did not identify the products.

Trials and Approvals

Ironwood Pharma (NASDAQ:IRWD) reported that China approved its treatment for irritable bowel syndrome with constipation (IBS-C) (see story). Ironwood, which is partnering the China marketing of the drug with AstraZeneca, expects to launch Linzess® (linaclotide) in China during the second half of 2019. Linaclotide is a guanylate cyclase-C (GC-C) receptor agonist that is approved in the US and more than 30 other countries. Ironwood estimates there are 14 million patients suffering from IBS-C in China.

Cellular Biomedicine (NASDAQ:CBMG), a Shanghai immunotherapy/stem cell company, reported that its off-the-shelf therapy for Knee Osteoarthritis (KOA) was approved to start a China Phase II trial (see story). AlloJoin® is an allogeneic adipose-derived mesenchymal progenitor cell (haMPC) product. It is the first allogeneic stem cell drug application approved for a KOA Phase II clinical trial in China. In December 2017, the China NMPA declared that all cell therapies must comply with the drug IND/NDA process. The AlloJoin IND was approved after a 60-day priority review.

Suzhou Innovent Biologics (HK:01801) has dosed the first patient in a China Phase I clinical trial of its anti-CD47 mAb (IBI188), an inhibitor of the "Don't Eat Me" pathway. By binding CD47, IBI188 is expected to promote the phagocytosis of tumor cells by macrophages. Innovent plans to conduct several clinical trials to assess the efficacy of IBI188 in multiple tumor types, including non-Hodgkin's lymphoma and ovarian cancer. Innovent emphasized that IBI188 has a different mechanism that the check point inhibitors PD-1, PD-L1 and CTLA-4.

BeiGene (NASDAQ:BGNE) (HK:06160), a Beijing oncology biopharma, was granted Breakthrough Therapy designation in the US for its Bruton's tyrosine kinase (BTK) inhibitor, zanubrutinib, in patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Zanubrutinib is currently being tested in seven Phase II and Phase III clinical trials, both alone and in combination with other agents. China's NMPA has accepted two NDAs for zanubrutinib, including one for R/R MCL.

Disclosure: None.

Editor's Note: The summary bullets for this article were chosen by Seeking Alpha editors.